Validation Engineer - Isolator Equipment
- Carlow
- Contract
- Full-time
Validation Engineer - Isolator
On site Carlow
AMC23440We are currently hiring for a Validation Engineer role with a rapidly expanding biopharmaceutical manufacturer based in Carlow. In this role you will support Isolator Airflow Visualisation/ VHP/HVAC Qualification.The ideal candidate will have 3+ years of experience in validation of sterile fill finish processes and equipment and a relevant degreeIn order to excel in this role, you will more than likely have:
- Experience in authoring, reviewing, executing and approving Isolator Airflow Visualisation/ VHP/HVAC Qualification documents.
- Considerable experience in a comparable role, with experience operating as individual contributor adding value to the business in a GMP manufacturing setting, as well as the following qualifications/skills:
- Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification, the successful candidate will also have a proven track record in delivering excellence.
- Exception / Deviation Management and Change Control.
- Demonstratable experience of leading technical related projects.
- Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable
- Equipment and process validation.
- Sterile Fill-Finish processes and equipment.
- Filter Validation
- CCI qualification
- Shipping Qualification
- Equipment Periodic Validation
- Equipment Validation Lifecycle
- Project Management Skills/Qualification
- Autoclave/SIP Sterilisation Validation
- Dry Heat Sterilisation
- Cleaning Validation
- Controlled Temperature Units/Equipment Qualification
- Vial and Syringe Processing Technologies